Actively Recruiting

Phase Not Applicable
All Genders
Healthy Volunteers
NCT06527326

the Study of the Association Between the Gut Microbiota and Central Serous Chorioretinopathy

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2024-07-30

400

Participants Needed

1

Research Sites

109 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

To investigate the potential association between gut microbiota and central serous chorioretinopathy (CSC), we have observed in our clinical practice that CSC patients often experience chronic gastrointestinal issues. This observation has led us to hypothesize that CSC may be associated with gut dysbiosis. The Bifidobacterium genus is widely recognized as a beneficial gut bacterium, and numerous well-established Bifidobacterium supplements are available on the market. To explore this possible connection, we will collect fecal samples from both CSC patients and healthy individuals. Using whole-metagenome shotgun sequencing, we will compare the gut microbiota compositions of the two groups to determine if significant differences exist. Additionally, we will randomly assign patients to two groups: one group will receive Bifidobacterium supplements for at least one month, while the other group will receive a placebo. We will then assess whether the group receiving the supplements experiences faster recovery and lower relapse rates compared to the placebo group.

CONDITIONS

Official Title

the Study of the Association Between the Gut Microbiota and Central Serous Chorioretinopathy

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 60 years
  • Diagnosis of acute central serous chorioretinopathy (CSC) with typical manifestations shown by FFA and ICGA
  • Presence of subretinal fluid at the macular fovea
  • Disease duration of 6 months or less
  • Best Corrected Visual Acuity (BCVA) between 53 and 86 letters
  • No significant systemic diseases
  • Signed informed consent and ability to commit to follow-up
Not Eligible

You will not qualify if you...

  • Presence of significant systemic diseases
  • Best Corrected Visual Acuity (BCVA) of 20/200 or worse
  • Presence of choroidal or retinal atrophy in the macular fovea of the affected eye
  • Presence of choroidal neovascularization, age-related macular degeneration, polypoidal choroidal vasculopathy, diabetic retinopathy, choroidal hemangioma, pigment epithelial detachment, or similar conditions in the affected eye
  • High myopia in the affected eye

AI-Screening

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Trial Site Locations

Total: 1 location

1

2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hanzhou, Zhejiang, China, 310000

Actively Recruiting

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Research Team

W

Weixin Zheng, master

CONTACT

P

Panpan Ye, doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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